Ruxience
Riabni (rituximab or rituximab-arrx) is an anti-CD20 monoclonal antibody. It’s used to treat certain blood cancers (e.g., chronic lymphocytic leukemia) and autoimmune conditions (e.g., rheumatoid arthritis). Ruxience (rituximab) is given as an infusion through the vein (IV), usually at an infusion center. This is so your care team can monitor and treat you for any serious infusion-related reactions, such as trouble breathing and swelling. Other possible side effects of this medication include rash and infection. Ruxience (rituximab) is a biosimilar to Rituxan (rituximab), but it’s not yet FDA-approved to treat all conditions Rituxan (rituximab) is approved for.
What is Ruxience (rituximab)?
What is Ruxience (rituximab) used for?
Blood cancers
- Certain types of CD20-positive non-Hodgkin’s lymphoma (NHL) in adults
- CD20-positive chronic lymphocytic leukemia (CLL) in adults
Autoimmune conditions
- Moderate to severe rheumatoid arthritis (RA) in adults
- Granulomatosis with polyangitis (GPA) and microscopic polyangitis (MPA) in adults
How Ruxience (rituximab) works
Ruxience (rituximab) is an anti-CD20 monoclonal antibody. It targets specific cells in your immune system called B cells. B cells are involved in many different health conditions. For example, sometimes they can turn into cancer cells, and other times they become too active, which can cause autoimmune conditions.
Ruxience (rituximab) works by attaching to a specific protein in B cells called CD20. When it attaches to this protein, it signals the body to attack and kill that cell. As a result, these abnormal or overactive B cells can’t grow, spread, or work as well.
Drug facts
More on Ruxience (rituximab) essentials
Side effects of Ruxience (rituximab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Fever (up to 53%)
- Lower white blood cell count (48%)
- Chills (up to 33%)
- Infection (31%)
- Weakness (up to 26%)
- Nausea (up to 23%)
- Headache (up to 19%)
- -Diarrhea (up to 17%)
- Muscle spasms (up to 17%)
- Lower red blood cell count (up to 16%)
- Swelling (up to 16%)
- Night sweats (15%)
- Rash (15%)
Less Common Side Effects
- Trouble sleeping
- Stomach pain
- Cough
- Itching
- Vomiting
- Joint stiffness
- Nosebleeds
- Runny nose
- Tiredness
Ruxience (rituximab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Infusion-related reaction: swelling, trouble breathing, chest pain, low blood pressure, red skin
- Serious skin reaction: painful blisters, skin wounds, peeling skin, fever, sore throat, body aches
- Tears in the gut: sudden and severe stomach pain, fever, chills, and nausea or vomiting that won’t go away
- Infection: fever, chills, cough, muscle aches, very fast heartbeat, severe tiredness
- Tumor lysis syndrome: seizures, hallucinations, nausea, tiredness, no appetite, dark-colored urine, muscle cramps, numbness
- Serious heart problems: tiredness, weakness, dizziness, feeling faint, trouble breathing, pressure on the chest, pounding heart, irregular heart beat, sweating, feeling anxious, nausea
The following Ruxience (rituximab) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Black, tarry stools
bleeding gums
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in the urine or stools
blurred vision
body aches or pain
burning or stinging of the skin
chills
confusion
difficulty with breathing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
ear congestion
flushed, dry skin
fruit-like breath odor
headache
increased hunger
increased thirst
increased urination
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
lower back or side pain
nervousness
noisy breathing
pain or tenderness around the eyes and cheekbones
painful cold sores or blisters on the lips, nose, eyes, or genitals
painful or difficult urination
pale skin
pinpoint red spots on the skin
pounding in the ears
seizures
slow or fast heartbeat
sores, ulcers, or white spots in the mouth or on the lips
stomach pain
stuffy or runny nose
sweating
swelling of the tongue or throat
swollen glands
tightness of the chest
tingling of the hands or feet
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
vomiting
Less common
Blistering, peeling, or loosening of the skin
blisters on the trunk, scalp, or other areas
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
decreased frequency and amount of urine
difficulty with moving
discouragement
feeling sad or empty
irregular heartbeat
irritability
joint or muscle pain
loss of appetite
loss of interest or pleasure
lump or growth on the skin
muscle cramp, pain, or stiffness
numbness or tingling in the hands, feet, or lips
painful blisters on the trunk of the body
pain or redness at the injection site
pain, swelling, or redness in the joints
pounding or irregular heartbeat or pulse
red skin lesions, often with a purple center
red, itchy lining of the eye
redness of the face, neck, arms, and occasionally, upper chest
stabbing pain
trouble concentrating
trouble sleeping
Incidence not known
Blue-yellow color blindness
blurred vision or other change in vision
burning or stinging of the skin
decreased vision
dilated neck veins
extreme tiredness or weakness
eye pain, tearing
feeling of discomfort, illness, or weakness
irregular breathing
nosebleed
painful cold sores or blisters on the lips, nose, eyes, or genitals
sensitivity of the eye to light
severe abdominal or stomach pain
severe vomiting, sometimes with blood
sores, welts, or blisters
stomach cramps
swelling, stiffness, redness, or warmth around many joints
swollen lymph glands
vision loss
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Agitation or anxiety
bone pain
burning, dry, or itching eyes
change in taste
discharge, excessive tearing
excessive muscle tone
feeling of constant movement of self or surroundings
increase in body movements
lightheadedness
muscle tension
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
sensation of spinning
sleepiness
swelling of the stomach
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Ruxience (rituximab)
Pros
- Works in a more targeted, specific way than chemotherapy
- Might only need a dose once every 6 months for certain conditions
- Doesn’t typically cause hair loss
Cons
- Each infusion can last over 3 hours, so can be inconvenient
- Might cause infusion reactions
- Higher risk of infections can last a year after your last dose (sometimes longer)
Pharmacist tips for Ruxience (rituximab)
- How often you need a Ruxience (rituximab) infusion depends on your medical condition and how your body responds to the medication. Make sure you know when your infusions are scheduled and mark the dates on your calendar so you don’t miss a treatment. There are also several apps for your phone that can help you keep track.
- Each Ruxience (rituximab) infusion appointment can last almost the full day because of the time it takes to receive premedications and Ruxience (rituximab) infusion. Please plan accordingly for this time. Make sure you dress comfortably, bring water and food, and have something to help you pass the time, such as a book or music.
- Your oncologist will give you premedications, such as steroids, acetaminophen (Tylenol), and antihistamines, before each Ruxience (rituximab) infusion. These medications can help lower the risk of an infusion-related reaction, which can be very serious.
- Check your temperature regularly, such as once a day, when you’re receiving Ruxience (rituximab) treatment. Call your care team immediately if your temperature is 100.4 degrees Fahrenheit or higher; this means you have a fever. It’s important for your oncologist to know if you get sick, and sometimes a fever might be the only sign that you’re sick.
- If you experience nausea and vomiting while receiving Ruxience (rituximab), contact your oncologist. There are several antiemetic medications, such as ondansetron (Zofran) or promethazine (Phenergan), your oncologist might prescribe to help manage it.
- We don’t know if Ruxience (rituximab) passes into human milk. But, because of the risks to a nursing infant, you shouldn’t breastfeed while taking Ruxience (rituximab) and for 6 months after the last dose.
Common questions about Ruxience (rituximab)
Ruxience (rituximab) works more like an immunotherapy than a chemotherapy. Chemotherapy works by attacking all cells that grow very quickly, while immunotherapy works by using your own immune system to target cancer cells. But there are actually many types of immunotherapy for cancer and they affect your immune system differently. For example, some medications activate all of your immune cells to fight cancer. But other medications, like Ruxience (rituximab), only target specific immune cells. So while Ruxience (rituximab) is sometimes referred to as immunotherapy in the broad sense of the term, it's more often considered a targeted therapy.
People taking Ruxience (rituximab) might experience infusion reactions. These reactions are most common during the first infusion. Symptoms might include rash and red skin, chest pain, swelling, and trouble breathing. Some people have reported life-threatening reactions, such as throat swelling, anaphylaxis, or heart attacks. Your oncologist will give you several medications, such as acetaminophen (Tylenol) and diphenhydramine (Benadryl), before your Ruxience (rituximab) dose to lower your risk of a reaction. Your nurse will also monitor you very closely, especially during your first dose. You should tell your nurse right away if you have symptoms of a reaction during your treatment.
There aren’t any specific foods or drinks you need to avoid after receiving Ruxience (rituximab). It’s a good idea to stay home and rest the day after your infusion, especially after the first few doses when you’re still learning how your body might react to the medication. It’s possible that you might experience an infusion-related reaction up to 24 hours after your treatment. Tell your oncology care team right away if you experience symptoms, such as trouble breathing or rash, so you can get immediate medical attention.
How long the side effects Ruxience (rituximab) last can differ depending on what side effects you’re experiencing. For example, fever, rash, muscle pain from infusion-related reactions can appear quickly, often times within 2 hours of an Ruxience (rituximab) infusion. But these side effects are short-lived because your care team can help you manage them quickly with other medications. Other side effects of Ruxience (rituximab), such as having a weaker immune system (from low white blood cell counts), can last months after your last dose. Talk to your oncologist if you have questions on any particular Ruxience (rituximab) side effect.
Ruxience (rituximab) is a biosimilar to Rituxan (rituximab). A biosimilar is a biologic medication that’s very similar to the original biologic that was first approved by the FDA. Biosimilars are as safe and work similarly as well as the original biologic medication. Ruxience (rituximab) isn’t approved to treat all the same conditions or all the same age groups as Rituxan (rituximab). Talk to your oncologist if you have questions about biosimilars.
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Risks and warnings for Ruxience (rituximab)
Ruxience (rituximab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infusion-related reactions
People taking rituximab products might experience infusion-related reactions. These reactions are most common within the first two hours of the first infusion. Symptoms include rash and red skin, swelling, trouble breathing, chest pain, irregular heartbeat, and low blood pressure. Sometimes, these reactions can be very serious and cause throat swelling, anaphylaxis, or heart attacks. This can be life threatening.
You’ll take several medications before each treatment, such as acetaminophen (Tylenol) and diphenhydramine (Benadryl) to help prevent a reaction. Your nurse will watch you closely during your first treatment, but you should tell them right away if you experience any symptoms during your treatment. If you have a severe reaction to Ruxience (rituximab), you might not be able to continue taking the medication.
Serious skin reactions
Some people receiving rituximab products have experienced serious and sometimes life-threatening skin problems, such as Stevens-Johnson syndrome (SJS), paraneoplastic pemphigus, toxic epidermal necrolysis (TEN), and others. Tell your provider right away if you develop painful blisters, skin wounds, peeling skin, or fever as these are signs of a serious skin reaction that need immediate medical attention.
Hepatitis B reactivation
- Risk factors: History of hepatitis B viral infection
Some people who had hepatitis B in the past experienced a new infection (hepatitis B reactivation) after starting medications like rituximab. Your oncologist will test you for hepatitis B virus before you start taking Ruxience (rituximab). If you test positive, you might need treatment for hepatitis B before you start taking Ruxience (rituximab). If you develop a hepatitis B infection during treatment, you’ll need to stop taking Ruxience (rituximab) while your oncologist treats it. Let your oncologist know right away if you experience symptoms of an active hepatitis B infection, such as fever, tiredness, or yellowing of the skin.
Progressive multifocal leukoencephalopathy
- Risk factors: Taking Ruxience (rituximab) with chemotherapy | Taking Ruxience (rituximab) for stem cell transplant
Rarely, people taking Ruxience (rituximab) have developed a serious brain condition called progressive multifocal leukoencephalopathy (PML). PML is caused by a virus called JC virus and can lead to brain damage. Let your oncologist know if you’ve PML symptoms while taking Ruxience (rituximab), such as weakness, clumsiness, difficulty speaking, and difficulty walking.
Tumor lysis syndrome
- Risk factors: People taking Ruxience (rituximab) for lymphoma
Some people taking medications like Ruxience (rituximab) to treat cancer developed a complication called tumor lysis syndrome (TLS) that can cause damage in multiple areas of the body. TLS happens when cancer cells are destroyed and release what’s inside them, such as potassium and uric acid, into your blood. TLS is most common during the first treatment cycle, and symptoms can appear within 24 hours of the Ruxience (rituximab) infusion. Your oncologist will closely monitor you with lab tests, and might give you extra fluids or a medication such as allopurinol (Zyloprim) to prevent TLS. Let your oncology care team know if you experience symptoms of TLS, such as nausea, tiredness, and no appetite.
Serious infections
- Risk factors: Taking Ruxience (rituximab) with chemotherapy
People who take rituximab products like Ruxience (rituximab) can develop serious infections, including viral, bacterial, and fungal infections. If you do get sick, you might need to pause taking Ruxience (rituximab) and start taking other medications to treat the infection. If you develop a serious infection you might have to stop taking Ruxience (rituximab) altogether. Contact your oncologist if you develop signs and symptoms of an infection such as fever, chills, muscle aches, or severe tiredness or weakness.
Serious heart problems
Serious heart problems have happened during treatment with medications like Ruxience (rituximab). These include heart rhythm changes and heart attacks. If your heart rhythm changes during your treatment, your oncologist might recommend closer monitoring with a test called an electrocardiogram (EKG) during your infusions. If you develop serious heart problems during treatment, your oncologist might stop your Ruxience (rituximab) infusion.
Kidney problems
Risk factors: Tumor lysis syndrome | Taking cisplatin Some people taking medications like Ruxience (rituximab) experienced kidney problems. This was more common in people who developed tumor lysis syndrome or who were taking Ruxience (rituximab) together with a chemotherapy medication called cisplatin. Your oncologist will monitor your kidney health with a blood test while you’re taking Ruxience (rituximab). Let your oncologist know if you have trouble making urine, notice swelling in your hands and feet; these might be symptoms of kidney problems.
Gut blockage and tears
Some people have reported stomach pain, intestinal blockage, and tears in the lining of the gut after starting medications like Ruxience (rituximab) together with chemotherapy for NHL. For some people, these side effects appeared 2 months after the start of treatment. Contact your oncologist right away if you have sudden and severe stomach pain, fever, chills, and nausea or vomiting that won’t go away.
Vaccines
Make sure you’re up-to-date with your vaccines before starting Ruxience (rituximab). We don’t know if it’s safe to take live virus vaccines while taking Ruxience (rituximab). You should avoid live vaccines during treatment. And you need to receive any non-live vaccines at least 4 weeks before Ruxience (rituximab) treatment. Talk to your oncologist before getting any vaccine while you’re taking Ruxience (rituximab), even if it’s an inactivated vaccine.
Harm to unborn baby
Based on data from human pregnancies, Ruxience (rituximab) can cause harm to an unborn baby. If you’re a female who's able to have babies, you should use effective birth control while taking Ruxience (rituximab) and for 12 months after the last dose. Contact your oncologist right away if you become pregnant while taking Ruxience (rituximab).
Combination treatment for people with autoimmune conditions
Risk factors: People taking Ruxience (rituximab) for autoimmune conditions We don’t know if it’s safe to take other biologic medications or disease-modifying antirheumatic drugs (DMARDs) together with Ruxience (rituximab). Because taking these medications together might raise your risk for infection, your provider will closely monitor you if they recommend a combination treatment.
Ruxience (rituximab) dosage
Typical dosage for Ruxience (rituximab)
Blood cancers
Your oncologist will determine your dose of Ruxience (rituximab) based on your body surface area (BSA) in m². Your oncologist might also give you other anticancer medications along with Ruxience (rituximab).
-
Non-Hodgkin’s lymphoma
- Adults: The typical dose is 375 mg/m² given as an intravenous infusion. How often you’ll receive a dose usually ranges from weekly to every 8 weeks, depending on the type of NHL you have and where you are in the treatment process.
-
Chronic Lymphocytic Leukemia (CLL)
- Adults: The typical dose is to receive one 375 mg/m² intravenous infusion before the start of chemotherapy. Then, your oncologist will raise your dose to 500 mg/m² infused on Day 1 of a 28-day chemotherapy cycle, for up to 6 cycles.
Autoimmune conditions
Your HCP might also give you other medications along with Ruxience (rituximab) to treat your condition.
-
RA
- Adults: The typical starting dose is 1,000 mg infused IV for 2 doses, given 2 weeks apart. The typical maintenance dose is 1,000 mg infused once every 4 to 6 months, depending on your condition.
-
GPA and MPA
- Adults: Your HCP will determine your dose of Ruxience (rituximab) based on your body surface area (BSA) in m². The typical starting dose is 375 mg/m² given as an intravenous infusion weekly for 4 weeks. The typical maintenance dose is 500 mg given as 2 doses 2 weeks apart, then 500 mg every 6 months.
Interactions between Ruxience (rituximab) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Varicella Virus Vaccine, Live
- Zoster Vaccine, Live
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abatacept
- Adenovirus Vaccine
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Cisplatin
- Dengue Tetravalent Vaccine, Live
- Infliximab
- Influenza Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Smallpox Vaccine
- Tofacitinib
- Typhoid Vaccine, Live
- Yellow Fever Vaccine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Influenza Virus Vaccine (Subvirion)
- Pneumococcal Vaccine Polyvalent
What are alternatives to Ruxience (rituximab)?
